Medicine and the law

If you’ve given your infant or children liquid Tylenol or liquid Motrin, you may want to re-think that and find something equally as effective to treat fevers. McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, pleaded guilty to a federal criminal charge that it sold the over-the-counter liquid medicine that contained metal particles.

The company also acknowledged failing to take corrective action after discovering the tainted bottles of Children’s Tylenol and Children’s Motrin. McNeil agreed to pay $25 million to resolve the case.

Metal particles including iron, chromium and nickel were introduced during the manufacturing process at the company’s Fort Washington, Pennsylvania plant. Prosecutors say McNeil knew about the problems for nearly a year, and yet did nothing to take immediate steps to fix it.

Miraculously, and thankfully, prosecutors say that no one was injured. However, an Acting Assistant Attorney General said in a statement after a judge accepted McNeil’s plea, “McNeil’s failure to comply with current good manufacturing practices is seriously troubling.”

He said also that the Justice Department will continue to aggressively pursue and prosecute companies, such as McNeil, that disregard processes designed to assure quality medicines.

This case has been ongoing since 2009, when a consumer complained about finding black specks inside a bottle of Infant’s Tylenol. Subsequently, McNeil found metal particles in the production process, but did nothing about it.

The company eventually traced the problem to a machine in its Fort Washington plant and issued a recall. The Food and Drug Administration said the potential for serious injury was small, but advised consumers to stop using the products.

Interestingly, the Philadelphia plant was destroyed in 2010, and a new plant has been built to replace it. The new plant, however, has not opened.

The FDA is now monitoring the company with increased inspections and oversight at its factories.


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